Pharmaceutical analysis apparatus and method
Inactive Publication Date: 2010-05-27
DISTEK
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- Abstract
- Description
- Claims
- Application Information
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Benefits of technology
[0006]It is an object of the present invention to provide a more accurate process and apparatus for analyzing and / or predicting release of active agents from pharmaceutical and pharmaceutical-like products.
[0007]It is another object of the present invention to provide such a process and apparatus that more adequately replicates or simulates the conditions found in the GI tract.
[0008]It is another object of the present invention to provide such a process and apparatus that more adequately replicates or simulates the conditions found in the oral cavity.
[0009]It is yet another object of the present invention to provide such a process and apparatus that more efficiently performs such analysis and / or prediction of the active agent(s) release.
[0010]These and other objects and advantages of the present invention are provided by an apparatus for analyzing the release of an active agent(s) from a pharmaceutical product or pharmaceutical-like product, which more accurately simulates the conditions in the GI tract by applying forces to the dosage form. The frequency, duration and amount of force or compression that is applied to the dosage form can be controlled and preferably varied. This is preferably done by a programmable logic computer (PLC). The analysis device is preferably retro-fitable to existing dissolution devices to render such contemporary devices more accurate in simulating the conditions in the GI tract and oral cavity.
Problems solved by technology
The contemporary dissolution devices suffer from the drawback of failing to adequately replicate the conditions that a dosage form encounters in the gastro-intestinal (GI) tract, e.g., the stomach and / or intestine.
None of these contemporary devices simulates or accounts for the forces applied to the dosage form due to the digestive conditions and peristaltic actions along the GI tract.
Method used
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[0022]Referring to the drawings, and in particular FIG. 1, a pharmaceutical product or dosage form 10 traveling along the human GI tract is subjected to forces from a variety of sources including food and liquids that are present therein, mastication and other “oral cavity effects”, digestive muscular contractions, mass movement, compression, peristalsis, and other forces. These forces act upon the dosage form 10, effecting the release of the dosage form's active agent(s). It should be understood that while the following disclosure describes the pharmaceutical product or pharmaceutical-like product as a dosage form 10, the present invention contemplates analysis of any type of pharmaceutical product or pharmaceutical-like product that has an active agent(s) which is released, such as, for example, tablets, capsules, caplets, chewing gum, lozenges, pastilles, or other dosage forms.
[0023]Referring to FIGS. 2 through 5, a preferred embodiment of the pharmaceutical analysis apparatus or...
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An apparatus and method are provided for analyzing the release of active agent(s) from pharmaceutical and pharmaceutical-like products. The apparatus and method provide for more accurate simulation of the conditions in the GI tract and oral cavity including forces that are applied to the dosage form.
Description
FIELD OF THE INVENTION[0001]The present invention relates to the analysis of pharmaceutical and pharmaceutical-like products. More particularly, the present invention relates to an apparatus and process for analyzing and / or predicting the release of active agents in pharmaceutical and pharmaceutical-like products.BACKGROUND OF THE INVENTION[0002]Contemporary dissolution devices include a basket-type, a paddle-type and a reciprocating cylinder-type flow through device (USP IV). For example, the contemporary paddle type dissolution apparatus has a glass, round-bottomed vessel with an impeller mixing the contents of the vessel. The apparatus can also have an auto-sampler shaft inserted into the vessel to collect samples at selected intervals of time from an aqueous solution in the vessel. A tablet to be analyzed is dropped into the vessel and falls to the bottom of the vessel, where it sits during the dissolution run. The basket and reciprocating cylinder-type dissolution devices simil...
Claims
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Login to View More IPC IPC(8): G01N33/00G09B23/28
CPCG01N2013/006G01N33/15G01N3/08
Inventor BURKE, MATTHEW D.KALANTZI, LIDAPARR, ALAN FRANK
Owner DISTEK